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EC number: 262-811-8 | CAS number: 61477-96-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 977
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, 6-[[[[(4-ethyl-2,3-dioxo-1-piperazinyl)carbonyl]amino]phenylacetyl]amino]-3,3-dimethyl-7-oxo-, monosodium salt, [2S-[2α,5α,6β(S*)]]-
- EC Number:
- 261-868-6
- EC Name:
- 4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, 6-[[[[(4-ethyl-2,3-dioxo-1-piperazinyl)carbonyl]amino]phenylacetyl]amino]-3,3-dimethyl-7-oxo-, monosodium salt, [2S-[2α,5α,6β(S*)]]-
- Cas Number:
- 59703-84-3
- Molecular formula:
- C23H26N5O7S.Na
- IUPAC Name:
- sodium;(2S,5R,6R)-6-[(2S)-2-[4-ethyl-2,3-dioxopiperazin-1-yl)carbonylamino]-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: dilution with water.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- SPF
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Nippon CLEA Co., Ltd.
- Age at study initiation: 6 or 8 weeks, 12 or 16 weeks and 1 week old. The LD50 were compared in the three stages of growth.
- Weight at study initiation: 6-8 weeks: (6 weeks old: males =1 80-200 g, females = 110-130 g ; 8 weeks old: males = 220-290 g, females = 160-195 g), 12-16 weeks (body weight: 12 to 23 weeks old male 300 to 350 g, female 200 to 240 g, 16 week old male 400 to 450 g); 1 week: one male, 13 to 25 g.
- Diet: ad libitum
- Water: tap water ad libitum
- Acclimation period: one week.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2ºC
- Humidity (%): 60 ± 5%
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- water
- Doses:
- 8 and 10 g/kg-bw
- No. of animals per sex per dose:
- 7 animals per sex per dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 7 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, macroscopic observations. - Statistics:
- Litchfield-Wilcoxon's method.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 8 weeks old rats
- Mortality:
- No mortalities occured.
- Clinical signs:
- other: Mild locomotor suppression was the only transient effect observed.
- Gross pathology:
- No macroscopic abnormalities.
Any other information on results incl. tables
Table 1. Death rate in acute toxicity tests of T-1220.
Dose (g/kg) |
Male |
Female |
||||||||||||||||
Time in days |
Death Rate |
Time in days |
Death Rate |
|||||||||||||||
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
|||
8.00 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/7 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/7 |
10.00 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/7 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/7 |
Table 2. Summary of results.
Animal |
Route |
Age |
LD50 (g/kg) |
|
Male |
Female |
|||
Rat |
p.o. |
8w |
> 10 |
> 10 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- EU criteria
- Conclusions:
- The oral LD50 of the test item in rats was > 10000 mg/kg-bw.
- Executive summary:
An acute oral toxicity study was conducted in order to determine the toxicological properties of the sodium salt of piperacillin with a method similar to OECD guideline 401 (non-GLP). The test item was administered p.o. to two groups of 7 rats per sex at doses of 8.0 and 10.0 g/kg-bw test item. Mortalities and clinical signs were monitored during 7 days post-dosing after which animals were necropsied and subjected to a gross examination. No mortalities occured, the clinical signs were limited to mild transient locomotor suppression, no gross abnormalities were observed at necropsy. The oral LD50 was found to be > 10 g/kg-bw in rats.
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